CompletedPhase 4

Albuterol Versus Xopenex in Treatment of Acute Asthma in the Emergency Department (ED)

United States101 participantsStarted 2005-09

Plain-language summary

The purpose of this study is to determine in a large, double-blind, randomized, prospective pediatric clinical trial whether the use of continuous levalbuterol (Xopenex) in addition to standard emergency department treatment for acute asthma exacerbations will improve the Forced Expiratory Volume in 1 sec (FEV 1) compared to the use of continuous racemic albuterol. The secondary objective is to correlate clinical (hospitalization rates and clinical asthma scores) with plasma levels of (S)-albuterol.

Who can participate

Age range6 Years – 17 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient is between the ages of 6 and 17 * Has previously been diagnosed with asthma by any physician * Has presented to the ED with an asthma exacerbation judged by a physician to be of a moderate or severe degree Exclusion Criteria: * Requires immediate resuscitation (attending physician) * Is pregnant and/or breast feeding * If possibly pregnant, negative pregnancy test attached * Has chronic lung diseases (i.e. cystic fibrosis) * Has an uncorrected congenital heart diseaseHas a suspected foreign body aspiration * Is allergic to albuterol and/or levalbuterol (Xopenex) * Has an initial FEV 1\>70% predicted

What they're measuring

Change in Forced Expiratory Volume in 1 Sec (FEV1) Measured in L/Sec

Timeframe: Baseline and 4 hours

Trial details

NCT IDNCT00585039

SponsorPhoenix Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-03

Results submitted2011-03-17

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